We're taking a proportionate approach to our technology appraisals.
We're applying light-touch, faster evaluations to simpler low-risk treatments.
This allows us to produce rapid guidance for these topics. It also makes sure we continue to have enough time for complex areas that need tailored support.
In 2022, we introduced the first phase of a new proportionate approach to technology appraisals.
We simplified, removed, or reconfigured parts of the appraisals process. This means we applied light-touch, faster approaches to simpler, low-risk treatments allowing us to produce rapid guidance for some topics.
We’ve recommended 6 treatments in the first phase of this project, benefitting around 175,000 patients.
This process helped speed up our technology appraisals process by up to 20 weeks (45%) and increased our capacity for guidance on more complex treatments.
Treatments recommended through the proportionate approach
- Bimekizumab for treating active psoriatic arthritis – 12 weeks faster than standard processes.
- Somatagron for treating growth disturbance – 7 weeks faster than standard processes.
- Nintedanib for treating idiopathic pulmonary fibrosis - 8 weeks faster than standard processes.
- Vutrisiran for treating amyloidosis - 20 weeks faster than standard processes.
- Eptinezumab for treating migraine - 8 weeks faster than standard processes.
- Nivolumab for resectable non -small-cell lung cancer - 9 weeks faster than standard processes.
How we developed the proportionate approach to technology appraisals
We carried out a series of pilots that involved new ways of working. These were developed using test-and-learn principles, exploring multiple ideas and developing them through direct experience in real technology appraisals.
We engaged with our stakeholders and industry partners throughout, to ensure we incorporated their real-time input and feedback into the project.
In July 2023, we carried out a consultation on these approaches. Following the consultation, the approaches will be incorporated into the health technology evaluation manual as part of standard process and methods.
Phase 2 of the proportionate approach
In phase 2, we are developing the following ways of working:
Pathway approach to technology appraisals
The number of new treatments for similar disease areas is increasing. At NICE, nearly half of our technology appraisals are in only 10 disease areas. This means that for some disease areas, we have to evaluate a large number of medicines in the same area.
However, there are capacity constraints across the pharmaceutical landscape which means NICE cannot just increase resources to meet the demand of the new medicines.
The pathway pilots are testing a different approach that would allow NICE to evaluate medicines for a disease area in a single economic model. This will make it much easier for practitioners and commissioners to understand how our guidance relates to each other. It will also allow us to reduce repetition in our guidance development process.
The pathway approach will include the use of real-world evidence, ensuring that our decisions reflect what is happening in the NHS.
What are the benefits of this approach?
The pathway approach uses a single model, which spans treatment options within a disease area. It can be used to make evidence-based decisions for multiple drugs or treatments over time, to improve the consistency of our recommendations. This helps avoid repetition of developing and reviewing models and makes it easier to understand how our guidance relates to each other.
We anticipate that the pathway approach will be a quicker and less resource intensive for all stakeholders, and will create coherent and useful advice.
The approach aims to reflect the real-world decisions patients and clinicians make about treatment choice in the NHS. It also allows NICE to explore the use of evidence from the NHS and other technological advances.
We also expect that the approach will make our processes more efficient. This is because it will allow multiple technologies in a disease area to be evaluated using a constantly evolving model.
How is NICE testing the pathway approach?
The renal cell carcinoma pilot includes a technology, cabozantinib with nivolumab (sponsored by Ipsen). This is currently being evaluated and will result in publication of NICE guidance on the topic. The non-small cell lung cancer pilot will not include any technologies to be evaluated, and will provide an alternative approach to developing a pathway model.
We are also developing a methods and process guide, which explains how we will include new technologies in a pathway approach. We will hold a consultation on this guide.
What are the possible uses of a pathway model?
NICE will provide more detail about how pathway models will be built and maintained, including how they will be kept up to date and how they will be quality assured in the methods and process guide. The methods and process guide will also outline the requirements of participating companies. To inform the development of this guide of the project NICE will facilitate engagement with stakeholders.
After consultation on the methods and process guide, if NICE takes the pathway approach into routine practice the economic models may be used for the assessment of new medicines and significant license extensions.
We will provide further detail on this in a forthcoming methods and processes guide.
How will NICE decide if a technology is routed through a pathway model or a different evaluation route?
Until the methods and process guide for the pathway approach has been consulted on and published there is no requirement for companies to be involved at this stage or be routed through a pathway model. If the pathway approach is progressed into routine practice, we expected that technologies will be routed through the pathway approach.
How can I get involved in the pathway approach?
We acknowledge that the pathway approach is different to our existing process. We are committed to engaging with stakeholders during its development. To find out more about this approach please email PATT@nice.org.uk
To get involved in the pilots please email PATT@nice.org.uk.
High value steps
Through this approach we will identify the most important parts of the appraisals process. This will allow us to consider ways of getting to these stages sooner, whilst maintaining the rigour and robustness of our appraisals processes.
We plan to explore these opportunities for continuous improvements to the appraisals process using simulated or retrospective pilots, while we continue to develop guidance using current methods and process.
Products with many indications
Some treatments are being licensed for many indications, such as immuno-oncology treatments.
Through this approach we will consider using alternative methods and processes for evaluating treatments we’ve looked at many times before, and for which more indications are expected.
We expect that this will speed up the process of appraisal decision making, allowing effective treatments to get to patients faster.
Rapid Entry to Managed Access
Rapid Entry to Managed Access (REMA) is an ongoing, explorative, joint piece of work between NICE and NHS England. The project seeks to build on the UK’s world-leading experience in managed access through the Cancer Drugs Fund (CDF) and the principles which have been formally established through the launch of the Innovative Medicines Fund (IMF).
Through this work, we’re exploring how we could potentially enable earlier patient access to the most promising new technologies, while ensuring value to taxpayers.
Find out more
- interim methods and processes manual
- proportionate approach to technology appraisals: final report 2022-23 (PDF)
- watch a webinar we hosted on the proportionate approach to find out how we carried it out (YouTube).
For further information, or to share your ideas, please contact: PATT@nice.org.uk.